Apparatus for transcutaneous electrical stimulation of the tibial nerve

Abstract

An electro-acupuncture device for controlling over active bladder is described. The device includes a housing, circuitry for generating electro-acupuncture stimulus disposed within the housing, and at least one strap for securing the housing to the ankle. The device also includes a pair of D-shaped electrodes received within the bottom outer surface of the housing. The housing of the device is flexible with a low profile and is shaped so that it is conformal to a person's ankle. When the device is strapped to a patient's ankle, the electrodes contact the ankle and provide electric stimulation to the tibial nerve within the ankle.

What is claimed is: 
     
       1. A nerve stimulation device for applying electrical stimulation to a nerve, the nerve stimulation device comprising:
 a) a housing having a top surface and an opposing bottom surface that extends from an annular sidewall, wherein the housing bottom surface is curved having a convex shape that outwardly extends away from the opposing top surface, and wherein the curved bottom surface is adapted to be contactable to an exterior surface of a human body; 
 b) at least two electrodes received through respective apertures that extend through the housing bottom surface; and 
 c) a pulse generating circuit enclosed within the housing operably connected to the electrodes, wherein the pulse generator is capable of generating an electrical pulse. 
 
     
     
       2. The nerve stimulation device of  claim 1  wherein the electrodes are substantially D-shaped having a straight edge and an arcuate edge, the electrodes being arranged within the aperture of the housing with the straight edges opposing each other. 
     
     
       3. The nerve stimulation device of  claim 1  wherein at least one strap is attachable to the housing, the strap adapted to secure the housing to the body, wherein the at least one strap is configured relative to the housing and the electrodes so that the electrodes are directly contactable to the skin of the human body when the nerve stimulation device is positioned on the body. 
     
     
       4. The nerve stimulation device of  claim 1  wherein a gasket having a first gasket aperture and a second gasket aperture dimensioned to receive the electrodes is disposed about the electrodes on the bottom outer surface of the housing. 
     
     
       5. The nerve stimulation device of  claim 1  wherein the housing is composed of a material selected from the group consisting of silicone rubber, acrylonitrile butadiene styrene, styrene, polycarbonate, neoprene and combinations thereof. 
     
     
       6. The nerve stimulation device of  claim 1  wherein the housing has a height to width ratio ranging from about 1 to about 3. 
     
     
       7. The nerve stimulation device of  claim 1  wherein the housing annular sidewall comprises an outer annular sidewall surface that resides about perpendicular to the top housing surface, wherein the outer annular sidewall surface has a beveled shape that curves distally from the annular sidewall. 
     
     
       8. The nerve stimulation device of  claim 1  wherein the pulse generating circuit is configurable to emit a constant current electrical pulse. 
     
     
       9. The nerve stimulation device of  claim 1  wherein the electrical pulse comprises a maximum current output of about 60 milliamps. 
     
     
       10. A nerve stimulation device for applying electrical stimulation to a nerve, the nerve stimulation device comprising:
 a) a housing comprising a first housing portion having a first housing portion outer perimeter that extends from a second housing portion having a second housing portion outer perimeter, wherein the second housing portion outer perimeter is greater than the first housing portion outer perimeter; 
 b) at least two electrodes positioned on an exterior surface of the second housing portion; 
 c) a pulse generating circuit enclosed within the first housing portion operably connected to the electrodes to provide an electrical pulse. 
 
     
     
       11. The nerve stimulation device of  claim 10  wherein the at least two electrodes comprise a substantially D-shaped electrodes having a straight edge and an arcuate edge, the electrodes being arranged on the housing with the straight edges opposing each other. 
     
     
       12. The nerve stimulation device of  claim 10  wherein the housing is composed of a material selected from the group consisting of silicone rubber, acrylonitrile butadiene styrene, styrene, polycarbonate, neoprene and combinations thereof. 
     
     
       13. The nerve stimulation device of  claim 10  wherein the housing has a height to width ratio ranging from about 1 to about 3. 
     
     
       14. The nerve stimulation device of  claim 10  wherein the electrical pulse comprises a maximum current output of about 60 milliamps. 
     
     
       15. The nerve stimulation device of  claim 10  wherein at least one input mechanism resides within a recessed portion that extends at least partially within an exterior surface of the first housing portion. 
     
     
       16. The nerve stimulation device of  claim 10  wherein the first housing portion is removably separatable from the second housing portion. 
     
     
       17. A nerve stimulation device for applying electrical stimulation to a nerve, the nerve stimulation device comprising:
 a) a housing comprising:
 i) a first housing portion having a first housing portion top surface opposed from a first housing bottom surface and a first housing portion outer perimeter; and 
 ii) a second housing portion having a second housing portion top surface opposed from a second housing bottom surface and a second housing portion inner perimeter that extends to a second housing portion outer perimeter, wherein the first housing portion is removably positioned within the second housing portion inner perimeter, and wherein the first housing portion bottom surface and the second housing portion bottom surface are about coplanar; 
 
 b) at least two electrodes positioned on the first housing portion bottom surface; and 
 c) a pulse generating circuit enclosed within the first housing operably connected to the electrodes, wherein the pulse generating circuit is capable of generating a constant current electrical pulse. 
 
     
     
       18. The nerve stimulation device of  claim 17  wherein at least one input mechanism resides within a recessed portion that at least partially extends within a top surface of the housing. 
     
     
       19. The nerve stimulation device of  claim 17  wherein the second housing portion comprises a tab portion that distally extends from the second housing portion outer perimeter. 
     
     
       20. The nerve stimulation device of  claim 17  wherein the housing has a height to width ratio ranging from about 1 to about 3.